A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia
NCT ID: NCT01814488
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2013-07-31
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Risk-Oriented Therapeutic Strategy for Adult Acute Myelogenous Leukemia
NCT00400673
Treatment of Adult ALL With an MRD-directed Programme.
NCT00358072
Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways
NCT05124288
Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
NCT04232241
Early Allogeneic Blood Stem Cell Transplantation in High-risk Acute Myeloid Leukemia (AML)
NCT00188136
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation.
The Data Safety Monitoring Board (DSMB) in collaboration with the Steering Committee (SC) will make periodic monitoring to ensure the safety of patients enrolled in to the study. In particular, DSMB will check the periodic safety reports of serious adverse events, the primary or secondary graft failure and treated related mortality (TRM) data generated by the Data Management Center. A safety report will be generated every 30 enrolled patients completed 100 days of follow-up.
The population for analysis in the trial will be the Intention to Treat (ITT) population. All patients enrolled in the study will be included in the ITT analysis.
This study will explore the feasibility, safety and efficacy of allogeneic stem cell transplantation from unrelated, cord-blood and haploidentical donor in patients with an active leukemia. Due to the lack of detailed information from literature and the absence of alternative curative options in this patient population, criteria for sample size assessment do not refer to a formal statistical power calculation. Therefore, GITMO will promote enrollment of all patients with active leukemia eligible to allogeneic SCT in all Italian centres with the aim to collect outcome variables in ITT in the widest and most representative cohort of this specific patient population.
The choice of 80 patients transplanted is based on feasibility reasons and the expected patient population with these characteristics referred to the main Italian Transplant Centres in two year. GITMO survey data on transplant activity points to an estimated accrual of 40 patients per year over a 24 months enrolment period. Criteria for defining sample size do not follow statistical power estimates in order to demonstrate difference between the alternative donor options.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
allogenic transplant
The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation as a potential curative procedure in a population of patients with chemoresistant acute leukemias. Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation.
allogeneic transplant
Allogenic transplant using either a Marrow Unrelated Donor or a Cord Blood unit or a family Haploidentical donor.
The conditioning regimen in standard use is:
Thiotepa (Tepadina) i.v. 5 mg/kg/daily (total dose 10 mg/kg) day -7 and -6;
Busulfan (Busilvex) i.v. 3,2 mg/kg/day (total dose 9,6 mg/kg) as a single daily dose day -5, -4, -3;
Fludarabine i.v. 50 mg/m2 (total dose150 mg/m2) day -5, -4, -3.
Primary antifungal prophylaxis is Micafungin 50 mg/die i.v. (1 mg/kg if \<40 kg) day 0 to engraftment. After engraftment continue antifungal prophylaxis according to local practice.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
allogeneic transplant
Allogenic transplant using either a Marrow Unrelated Donor or a Cord Blood unit or a family Haploidentical donor.
The conditioning regimen in standard use is:
Thiotepa (Tepadina) i.v. 5 mg/kg/daily (total dose 10 mg/kg) day -7 and -6;
Busulfan (Busilvex) i.v. 3,2 mg/kg/day (total dose 9,6 mg/kg) as a single daily dose day -5, -4, -3;
Fludarabine i.v. 50 mg/m2 (total dose150 mg/m2) day -5, -4, -3.
Primary antifungal prophylaxis is Micafungin 50 mg/die i.v. (1 mg/kg if \<40 kg) day 0 to engraftment. After engraftment continue antifungal prophylaxis according to local practice.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR)
Age \>=18\<=70
Unavailability of a HLA-matched related donor (MRD)
Performance status: ECOG\<=3
Written and signed informed consent
Life expectancy not severely limited by concomitant illness.
Exclusion Criteria
Positive pregnancy test
Any active, uncontrolled infection.
\-
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gruppo Italiano Trapianto di Midollo Osseo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fabio Ciceri, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Raffaele
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, , Italy
Policlinico
Bari, , Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, , Italy
Ospedale San Orsola
Bologna, , Italy
Ospedale Regionale Generale- Divisione Ematologia
Bolzano, , Italy
Ospedale Binaghi
Cagliari, , Italy
Ospedale Oncologico Businco
Cagliari, , Italy
Ospedale Ferrarotto - Ematologia
Catania, , Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, , Italy
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
Florence, , Italy
Ospedale Policlinico San Martino - IST
Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale Niguarda Ca' Grande
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -
Modena, , Italy
Cattedra di Medicina Interna ed Ematologia - Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano
Monza, , Italy
AO Ospedali Riuniti Villa Sofia - Cervello
Palermo, , Italy
Dipartimento Oncologico La Maddalena
Palermo, , Italy
Fondazione IRCCS San Matteo
Pavia, , Italy
Dip. di Ematologia - Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico - Ospedale Civile di Pescara
Pescara, , Italy
Ospedale G. Da Saliceto di Piacenza
Piacenza, , Italy
Cattedra di Ematologia - Policlinico
Roma, , Italy
Policlinico A. Gemelli
Roma, , Italy
Policlinico Universitario Tor Vergata
Roma, , Italy
U.O. di Ematologia e Trapianti di Midollo Osseo - Azienda Osp. S. Camillo-Forlanini / Padiglione Morgagni
Roma, , Italy
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Ospedale San Giuseppe Moscato
Taranto, , Italy
Azienda ospedaliera Città della Salute e della Scienza
Torino, , Italy
Centro Trapianti Metropolitano
Torino, , Italy
A.O. Santa Maria della Misericordia
Udine, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-004008-37 Gandalf-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.